Support for adolescents with HIV and depression
HIV Engagement and Adolescent Depression Support (HEADS-UP)
This study is testing whether different types of counseling can help teenagers with HIV in Malawi feel less depressed and stay engaged in their HIV care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 5 sites (Lilongwe and 4 other locations) |
| Trial ID | NCT06173544 on ClinicalTrials.gov |
What this trial studies
This pilot study randomly assigns 105 adolescents living with HIV to receive either standard care, an adapted intervention, or an enhanced intervention known as the Friendship Bench Intervention. This counseling approach aims to address depression and improve engagement in HIV care among adolescents in Malawi, where rates of viral suppression are low and depression is prevalent. The Friendship Bench is delivered by trained lay health workers and is based on problem-solving therapy, making it suitable for youth adaptation and peer support integration. The study seeks to develop and test resource-appropriate interventions that can be scaled up to improve mental health and HIV care engagement.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-18 diagnosed with HIV who exhibit symptoms of depression.
Not a fit: Patients outside the age range of 13-18 or those not diagnosed with HIV will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve mental health and HIV care engagement among adolescents living with HIV.
How similar studies have performed: Other studies have shown success with similar counseling interventions in low-resource settings, but this specific adaptation for adolescents is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 13-18 * diagnosed with HIV (vertically or horizontally) * scored ≥ 13 on the self-reported and previously used BDI-II * living in the clinic's catchment area with intention to remain for \> 1 year * willing to provide consent (age 18 or 16-17 years old and married (emancipated minors per Malawi law) or assent with parental consent (age 13-17) Exclusion Criteria: * Less than 13 or greater than 18 years of age
Where this trial is running
Lilongwe and 4 other locations
- Area 18 Health Centre — Lilongwe, Malawi (Recruiting)
- Area 25 Health Centre — Lilongwe, Malawi (Recruiting)
- Kawale Health Centre — Lilongwe, Malawi (Recruiting)
- Lighthouse Health Centre — Lilongwe, Malawi (Recruiting)
- UNC Project Malawi — Lilongwe, Malawi (Not_yet_recruiting)
Study contacts
- Principal investigator: Bradley N Gaynes, MD — University of North Carolina, Chapel Hill
- Study coordinator: Bradley N Gaynes, MD
- Email: bradley_gaynes@med.unc.edu
- Phone: (919) 445-0214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.